Regulatory CMC Manager – Small Molecule (Remote)

Vertex Pharmaceuticals LLC; United States; Remote; USD 96,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Chemistry Manufacturing Controls Manager to lead planning, preparation, and execution of a multi-product program in the international region. The role supports regulatory CMC documentation and cross-functional teams in regulatory activities.

Key duties include managing lifecycle strategy and submissions, coordinating content plans, and ensuring alignment with global regulatory CMC strategies. Remote EST hours and a 12-month contract are offered.

Qualifications

• Bachelor's degree in biology, chemistry, regulatory affairs or related life-science field.
• Typically requires 5 years of pharmaceutical industry experience.
• Experience supporting small molecule programs is required.

Responsibilities

• Execute lifecycle management strategy and submissions for marketed products in international regions.
• Plan and execute international regulatory CMC submissions with cross-functional alignment.
• Review CMC sections of regulatory submissions and manage agency interactions.
• Collaborate on global regulatory CMC strategies and submissions with Regulatory colleagues.
• Participate in cross-functional teams and act as primary regulatory CMC contact for assigned products.
• Support regulatory assessments on product compliance topics including change controls, deviations and GMP investigations.

Skills

Regulatory knowledge

Interpersonal skills

Problem solving

Cross-functional collaboration

Planning & prioritization

Education

Bachelor's degree in life science

Job description

Vertex Pharmaceuticals LLC is seeking a Chemistry Manufacturing Controls Manager to lead planning, preparation, and execution of a multi-product program in the international region. The role supports regulatory CMC documentation and cross-functional teams in regulatory activities.

Key duties include managing lifecycle strategy and submissions, coordinating content plans, and ensuring alignment with global regulatory CMC strategies. Remote EST hours and a 12-month contract are offered.